1100 participants 2 yrs accrual 3.5 yrs min f/up 80% power to detect 25% reduction in HR of death from any cause

Participants randomised 1:1 to Enzalutamide 160mg daily or conventional NSAA daily until disease progression or prohibitive toxicity. All participants are treated with LHRHA or surgical castration. Assessments at baseline, day 29, week 12, and then every 12 weeks from randomisation until evidence of clinical progression. Imaging with CT scan and WBBS at baseline and evidence of PSA or clinical progression. Tertiary objectives are to identify prognostic / predictive biomarkers. Archival tumour tissue and fasting bloods at baseline, week 24, and 1st progression (PSA/clinical) will be collected. Email: enzamet@ctc.usyd.edu.au Website: http://www.anzup.org.au/

Disclosure

C. Sweeney: Consulting with honoraria to declare with Asetallas, Janssen and Sanofi. All other authors have declared no conflicts of interest.